Global Pharmacovigilance of Veterinary Medicinal Products Where are
Global Pharmacovigilance of Veterinary Medicinal Products: Where are we now? Where can we go in the future? Linda Walter-Grimm, DVM Center for Veterinary Medicine November 2017 VICH Veterinary Outreach Forum
Why Pharmacovigilance? From VICH GL 24: “Pharmacovigilance of veterinary medicinal products (VMPs) can be defined as the detection and investigation of the effects of the use of these products, mainly aimed at the safety and efficacy in animals and safety in people exposed to the products. ” 2
VICH Electronic Standards Implementation Expert Working Group • History and purpose: – Management of individual adverse event reports (AERs) - VICH GL 24 – Management of periodic safety update reports (PSURs) – VICH GL 29 – Standardizing and harmonizing data elements of individual adverse event reports – VICH GL 42, standardizing electronic transfer of data – VICH GL 35 • Ongoing maintenance activities for standardized vocabularies and code lists are designed to adapt as the field of pharmacovigilance evolves and expands to different regions (e. g. , species/breeds lists, dosage forms, country codes, Ve. DDRA terminology) 3
Successful Implementation Example: FDA Center for Veterinary Medicine • CVM implemented receipt of VICH HL 7 GL 42 electronic adverse event messages in 2015 – Gateway to gateway electronic submissions system – Safety Reporting Portal • Impact as of fiscal year 2017: – CVM received over 100, 000 adverse drug event report messages in FY 2017 – 99% of those adverse drug event reports were received electronically – CVM’s ADE Database currently contains over 750, 000 cases 4
Recent Developments Impacting Veterinary Pharmacovigilance (PV) • Transparency: Open. FDA is under development – Application programming interfaces (API) will allow dynamic queries of ADE case data – It may be possible in the future to directly download case data in XML format (Personally identifiable information is protected and not released) • More sophisticated pharmacovigilance tools including big data analytics – Disproportionality analysis (frequentist and Bayesian statistics) – PV Software easily produces clinical sign frequency lists at Ve. DDRA hierarchy levels (SOC, HLT, PT, LLT) – Literature searches for ADEs are easier in some well-established literature databases (e. g. Pub. Med) with programs such as EMBASE PV Wizard 5
Future directions and challenges • Sharing data effectively: Can we leverage VICH standards and existing technologies and work toward a global PV database? Are paper reports still necessary? – Safety Reporting Portal is a free online tool that can create an adverse drug event XML message in harmonized format. Are there others that could be leveraged? – Globally harmonized product dictionary? – Can data be shared in a publically accessible format? • Are there opportunities to make improvements in periodic aggregate reporting, ensuring effective communication of safety issues? Regional versus global risks? 6
Questions for discussion: exploring the needs of the VICH Veterinary Outreach Forum Members – How does your region handle ADE reporting from industry and consumers? Is an adverse drug event database for individually reported cases maintained by regulatory authorities in your region? Do you utilize periodic safety update reports or some form of periodic analysis/aggregate reporting? – What additional pharmacovigilance resources/data are you currently using to support analysis? – What are your additional needs for developing pharmacovigilance programs in your region? (e. g. regulations, access to ADE data, education/training? ) 7
Thank you 8
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